Medtronic received information regarding a navigation device being used intra/peri-operatively of a functional endoscopic sinus surgery (fess) procedure.It was reported that the system was inaccurate after passing registration using trace and touch.The site had a metric of 1.0, there was a green sphere encompassing the entire sphenoid.The surgeon reported inaccuracy of 4 mm at the middle turbinate, appearing more inferior.The manufacturing representative (rep) measured the inaccuracy in the software and reported 8 mm.They added another touch point to inner canthus adjusting the metric to 1.2.The accuracy did not change.The surgeon appeared to be accurate in deeper portions of the anatomy.The inaccuracy was seen with the straight suction and tri-cut blade.There was no delay in the procedure and no impact on patient outcome.
|
H2, h3, h6: software archives were analyzed.It was determined that there was insufficient information to determine the root cause of the issue.Previously reported codes b01 and c19 are applicable, as is code d15.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|